A Foundation For Quality (and performance...)

Next week is ISPE’s annual meeting in Texas and once again I am participating in an interesting session titled “Operational Excellence - A Foundation for Quality”. We held a similar session last year and it was a great success with more than 90 people participating. The topic that I am covering this year is about the current capabilities of automation technology andinformation systems that provide a vital ingredient in enabling operational excellence. I will be joined by speakers from Pfizer, Celgene, Amway and of course NNE Pharmaplan.

My co-presenters will share experiences about OperationalExcellence, Quality by Design (QbD), and Process Understanding. All-in-all an interesting combination of topics that may initially seem loosely related but they are in fact deeply related. They stem from the some old notion that manufacturing performance is a holistic concept. I have mentioned in a previous post that we are “re-inventing the CIM wheel” but at the same time we are also looking at it in a new perspective with much more modern and usable technologies.  I strongly believe that before we venture with new ideas we have to look and learn from the past, it is very likely that somebody has had a similar problem and may even have a solution. So CIM, PAT, QbD, DFM it really is all related, related to trying to excel at we do and work more synergistically to accomplish our manufacturing goals. 

The 4 Misunderstanding About Manufacturing Systems Implementations

A few weeks ago I attended the ISPE annual meeting in Orlando. My company was hosting a session about technology and operational excellence that was pretty well attended. I take that as a sign of general interest in the topic. I believe that the interest was on the pure operational excellent side, yet the session tried to highlight the synergies that exist between manufacturing systems and operational excellence.

My colleague Carsten Holm Pedersen held a talk on the synergies between systems and operational excellence. The main theme of his talk was what he called “The 4 Myths” about manufacturing information systems or as I refer to them as “The 4 Misunderstanding” about Manufacturing System implementations. I really liked his message so I wanted to share it here.

Focus ROI
Sole focus on ROI ensures success because it defines qualitative business goals and sets a defined scope. However this also means that focus is diverted to “easy wins” rather than usable solutions and enhancement that have obvious value are ignored or rejected as “scope creep”. Furthermore there is risk that synergies from process improvement and other OpEx initiatives are not incorporated or supported by the system.


Use of Standard Systems
Application of standard systems is more effective and guarantees use of “Best Practices”. They reduce risk and provide superior maintainability. The reality is that these so-called “Best Practices” are not necessarily a good fit to your process and sometimes they are not “best” at all, but simply a result of “that is the way we have always done it” thinking. As such they sometimes do not provide the flexibility or adaptability to specific processes and force unnecessary constraints. Focus is diverted to “What we can buy” rather than “What we need”.


Competitive approaches increase productivity
Employing a competitive approach where different projects are competing for the same funds motivates and steers project teams to achieve better results. In fact just the contrary is true, this approach only ensures sub-optimization. It inhibits collaboration and does not leverage the inherent need for systems to be built to support the process. Systems are built to provide specific point solutions and not enable a streamlined lean manufacturing process or superior process understanding.


Integration should be avoided.
Interoperability between systems is not that important and if it is implemented has to be in real time. On the contrary one of the inherent attributes of Manufacturing Systems is interoperability with all levels in the manufacturing process. Not including interoperability with other system may seriously inhibit the usability of a solution and some obvious benefits to process visibility may be ignored. Also each interface may have different “real-time” requirements that have to be evaluated by needs and value.

There is obviously much more to these than what I can put in this post so let me know what you think and make sure to follow Carsten for more discussion on these topics.

Next week at AdvaMed2010 in DC

Next week I will be attending AdvaMed2010 in Washington DC in an attempt to mingle with the top of the food chain of the Medical Device industry. If you didn’t know AdvaMed is the premier industry organization for the Medical Device industry and the AdvaMed2010 conference is its annual meeting. Essentially it is a place for smaller Med Device companies to market themselves to venture capitalist and larger companies.

Medical Devices is one of our core markets at NNE Pharmaplan and hence we are hoping to leverage this event to make ourselves better known in the industry. Kind of old school marketing but I am hoping that there is value there? I look forward to an interesting week and getting to meet some interesting companies and people. Also last time I have been to DC is in 1995 so I am long due. If you are around give me a shout.

Common question - What MES should I use?

I just returned from the CBI MES conference and found that the main theme or at least that many the attendees were interested in finding the right MES. Yes I know - “it is maybe easier to achieve world peace”. It seems there is no clear answer – no surprise! “It depends”, was a common answer, some said “it is what you make of it”, and I completely agree.

In my many years of studying the “Shop Floor Management” (aka Manufacturing Systems) problem I found that apart from all the technical and functional aspects, the common element that makes an MES implementation and operation successful is user involvement. The users (across all functions) really have to want it! MESs are complex and sometimes cumbersome. They touch many different functions in a manufacturing business, most critically they manage the value stream – or where value is being made. That makes their adoption and acceptance brittle.

In most cases MES products are aligned with specific industries and hence it is pretty straightforward to make an initial short list. But this is not always true, a vendor may be trying to penetrate your specific vertical opening up potential to influence them – and possibly also get a good deal. There are obviously many other factors that can and do play in. “It depends” is always a true statement when talking about fit of a specific MES product to your environment, and therefore it is always important to know what you need.

So how do you determine what you need? Most people will tell you, and correctly so, that you have to use formal (true and tested) models such as the MESA model or the ISA 95 standard. This is the boring but necessary part of the preparatory and selection phases for the MES. I am not saying you should skip the detail; it is by all means necessary. We all know that the devil is in the details, but using these models with no clear focus will not help either. You should use these models to make sure that you have not forgotten or omitted something not to define your problem. That is something only you and your company know, and in most cases it is very specific to your company or business. I prefer to use the 5 whys method to get to the root-cause and then write up as a series of problems – in simple language.

Another important thing to remember is to build on success as Lean practitioners advocate. It works best with a focused Kaizen-like event where a specific need is addressed. When people in the company observe or have taken part in a successful change the value seems transparent and obvious - and you don’t have to even explain or sell it. It is infinitely easier to convince people this way. In fact the only really successful MES projects, at least in my experience, have been when the operators and engineers embraced the system because it addressed a specific problem they had. Yes I know this seems trivial and is also the basis of modern product management, but it is really much more challenging than it seems.

So what have we learned from all of this? As many of the speakers at the conference re-iterated; you need to have a clear focus of the problem. It makes it is easier to build a business case to justify the investment – trivial really. But at the end of the day you have to want it, otherwise it will never happen.

Next week at CBI MES conference

Next week I will be at the CBI MES conference in San Diego. It is set to be very interesting conference with a good representation from MES vendors but more importantly there is broad participation from the life science industry both Med Device and BioPharma. A great opportunity to learn how these companies have been able to leverage technology to improve performance and compliance. I will have my notebook ready since I need to get some good real-life examples for a session that helping to plan for the ISPE annual meeting. I have also been able to involve MESA and we are planning to promote the European Conference and other events.

I also look forward to the conference because I have never been to San Diego and the venue isn't to shabby either J. I hope to see many of you out there and do some catch-up. Follow me on Tweeter to get live updates from the conference if you are interested.

"Lean technology" a Manufacturing Systems perspective

My colleagues and I are in the process of preparing an educational session that will be held at the ISPE annual event in November. So as usual I spend some time looking through my archives for relevant material that I already have – I call it 're-cycling' :-). This time I came across something that I never published or used and so I thought I would share it here. It is an attempt to explore the synergies of the Lean and Manufacturing Systems concepts. Read and tell me what you think…

Manufacturing Technology; A familiar phrase considered part of the everyday vocabulary. What about Lean Technology? Not a common phrase, but the idea of lean manufacturing supported through technology should be as much a part of the vocabulary as Manufacturing Technology. Lean thinking advocates simplification of manufacturing units so they can be more easily shifted to enable the flow of value. So in essence the “lean technology” concept supplements lean thinking by combining state-of-the-art manufacturing with advanced software systems in an integrated environment.

Using information systems in lean manufacturing is not a new concept, nor is it new to the lean movement. Many examples exist that prove that manufacturing (software) system can support a lean organization. Unfortunately most commonly information technology systems for manufacturing tend to become large monolithic systems of great complexity. They are designed to provide generic functionality to fit major industry verticals that can be configured specifically for each implementation. At the same time the uniqueness and the complexities of the specific manufacturing operations make the ability to only configure these solutions more a myth than reality. Most of the system vendors will of course argue against this - however the reality is that in order to meet the requirements of the manufacturing businesses they are forced to implement complex customizations. That is what I wrote on my post about Customize or Compromise.

Although lean thinking advocates the application of a set of specific common concepts, the actual implementation of these concepts in real life tends to be unique to each production line and plant. Information systems that are used to support these lean lines and plants have to be able to provide common functionality to support these concepts. Yet, they also have to be able to support the uniqueness of each implementation. Furthermore they need to be able to support the changes that are inherent in a lean system due to the continuous improvements as they are accomplished.

In summary here is my suggestion for the general functionality of a Manufacturing System that can support a Lean manufacturing environment. (BTW I know that these go against the grain by not using a problem-oriented approach – I will have to redefine this ASAP)

• Value stream: We all know that value is identified by the specific needs of the customer hence the Manufacturing System should be usable and implementable to support only these specific processes that add value. In other words the system once implemented should not require or be constrained to use extra processes or involves extra steps if they are not directly part of the value flow.
• Implement flow: The Manufacturing System should employ a value centric process model that is easily managed and accessible to all the relevant people. This will allow a transparent view of the value flow and thus allow engineers and operators to ensure production flow, be it a one-piece flow, supermarkets, or other relevant Lean solutions.
• Execute Pull: This is kind of the obvious requirement that involves the enablement of pull execution and dispatching of WIP. This may include features and functionality to enable or enforce flow and managing kanbans, supermarkets, balancing, etc.
• Enable Perfection: Enable perfection by providing the production and process visibility needed for the continuous improvement efforts. This is the part of the system that provides Intelligence (a topic that I have written a few relevant posts about). In addition the Manufacturing System should provide adequate configurability, extendibility and customizability that support continuous improvement.

I am back, sorry for the delay...

It has been a while since I posted something here, and I have a long list of bad excuses. (Here is the last one).

It has been a very exciting and busy time for me and my family. We have relocated from Indiana to the San Francisco Bay Area with all the excitement and hard work that follows. I guess that we are getting settled now so I am going to try and pick-up the blogging just a bit. I have quite a few interesting things to share so I hope find some time over the next month to do some more blogging.

I have been involved in some very interesting projects. I am working with BioMarin helping them figure out what MES will work best for them and some of the strategies around implementation. I have also had a short stint with Amgen looking at their Manufacturing Business Intelligence initiative. Apart from that I have been involved with a few of the Bay Area Biotech companies while at the same time trying to find new customers in North America.

On the event front I am planning to be at CBI's annual MES event (San Diego, in Sep.), AdvaMed (Washington DC, in Oct.), and the ISPE annual meeting (Orlando, Nov.) where we are organizing an educational session on Operational Excellence. So if you are going to be at any of these events let me know so we can catch-up. It’s going to be an interesting and busy period.